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Completed

NCT Number: NCT05720416

Effects of a Multi-intervention Programme for the Elderly

1. To develop a multiactivity training programme. 2. To explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease. 3. To compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and quality of life of the elderly.

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Key information

Conditions

Sarcopenia Atrophy Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Muscular Atrophy Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenic Obesity Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daycare center at Central Taiwan University of Science and Technology

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) over 60 years old, (2) able to Communicate and follow instructions; (3) Stable condition with sufficient physical strength: able to maintain a seated position in a wheelchair or on the edge of a bed for at least one hour. (4) sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease.

Exclusion criteria

(1) difficulty in standing or walking and obvious musculoskeletal disease, (2) unsuitable for diagnosis by a physician those engaged in sports activities, (3) serious diseases/unstable states, such as severe heart, lung, liver and kidney diseases, severe malignant tumors, severe nutrition poor, severe dementia, (4) more than 180 minutes of exercise per week in the past month, (5) no willingness to participate.

Treatment and study plan

Protein supplementation

Dietary Supplement

protein supplementation for 16 weeks

Muscle strength training

Behavioral

muscle strength training for 16 weeks

Usual Care

Other

no intervention

Primary outcomes

  1. Chang in muscle strength from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    pinch, grip and quadriceps strength. A Higher score means a better outcome.

  2. Chang in weight of muscle and fat from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    muscle mass(kg), fat mass (kg)

  3. Chang in Activities of Daily Living from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    This is a scale of physical function. The range for total score is 0-100. A Higher score means a worse outcome.

  4. Chang in Instrumental activities of daily living from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    This is a scale of physical function. The range for total score is 0-24. A Higher score means a better outcome.

  5. Chang in Clinical Dementia Rating from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome.

  6. Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    Mental Function Assessment. The range for total score is 0-38. A Higher score means a worse outcome.

  7. Chang in Cohen-Mansfield Agitation Inventory from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    This is a scale of behavior measurement. The range for total is 29-203. A higher score means a worse outcome.

  8. Chang in EQ5D from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    This is a scale of quality of life. The range for total is 0-20. A higher score means a worse outcome.

  9. Chang in QUALIDEM from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    The scale is a dementia-specific Qol instrument. The range for total score is 0-120. A higher score means a better outcome.

  10. Demographic attributes

    Time frame: Baseline

    Gender, education, age, married status, religion, medication, diseases, work and height.

  11. Chang in PERSONAL WELLBEING INDEX from baseline to 16 weeks

    Time frame: Baseline and 16 weeks

    The range for total is 0-80. A higher score means a better outcome.

  12. Chang in PERSONAL WELLBEING INDEX intellectual disability from baseline to 16 weeks

    Time frame: Baseline and 16 weeks.

    The range for total is 0-70. A higher score means a better outcome.

  13. Chang in World Health Organization Quality of Life Instruments (WHOQOL-BREF) from baseline to 16 weeks

    Time frame: Baseline and 16 weeks.

    This is a scale of quality of life. The range for total is 26-130. A higher score means a better outcome.

  14. Chang in Four-Meter Gait Speed from baseline to 16 weeks

    Time frame: Baseline and 16 weeks.

    Measured with seconds. A higher score means a worse outcome.

Sponsors and collaborators

Lead sponsor

Central Taiwan University of Science and Technology

Other

Registry information

Official study title

Effects of a Multi-intervention Programme on the Muscle Strength, Body Composition, Physical Performance and Quality of Life of the Elderly

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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